Product Manager - Diagnostics (San Diego)

About Pluslife

Pluslife is a global molecular-diagnostics innovator transforming how infectious diseases are detected and monitored. Our assays and platforms are trusted in 40 + countries through collaborations with WHO, FIND, and the Gates Foundation.

We are now expanding our U.S. operations to bring affordable, clinically reliable, and regulatorily compliant testing closer to patients, clinicians, and veterinary professionals.

The Role

Were seeking a Product Manager with hands-on diagnostics or medical-device experience who thrives on translating clinical and laboratory needs into market-ready solutions. Youll connect assay development, engineering, regulatory, and commercial teams to ensure each product meets scientific, operational, and business standards for success.

Youll work across human and veterinary health programs, helping Pluslife build a portfolio that delivers clinical confidence and commercial scalability.

What Youll Do

• Own product lifecycle from concept through regulatory submission and launch (feasibility V&V clinical validation market release).
• Collaborate with R&D, QA / RA, and manufacturing teams to define requirements, design transfer criteria, and risk-management documentation (e.g., ISO 13485, FDA QSR).
• Partner with clinicians, veterinarians, and laboratory stakeholders to identify workflow pain points and translate them into user and product requirements.
• Conduct structured market and competitor analyses for diagnostic assays and POC systems.
• Support regulatory and clinical trial planning (510(k), CLIA-waived, EUA, or USDA-CVB for vet tests).
• Define commercialization readiness : labeling, instructions-for-use, training, post-market feedback loops.
• Build internal documentation and processes that strengthen Pluslifes product-development discipline in the U.S.

Who You Are

Why Join Pluslife

How to Apply

Send your LinkedIn profile and resume along with a brief note answering :

Describe a time you translated a clinical or laboratory requirement into a commercially viable diagnostic product.